Supplement Maker Warned by FDA for Misbranding and Procedural Violations

Per FDA News, Sanapac, a dietary supplement manufacturer, was notified by the Food and Drug Administration for GMP violations, adulterated products, and misbranding products after an inspection in 2016. After an inspection in November, FDA inspectors returned the following month and found numerous issues in regards to the lack of written Standard Operating Procedures for[…]

US and EU Sign Agreement to Mutually Recognize Drug Manufacturing Inspections

In 1998, the European Union (EU) and the US signed the Mutual Recognition Agreement (MRA) with provisions specifically about current Good Manufacturing Practices (cGMPs) for drugs but were unable to start implementation. Since 2014, both the US and European Medicines Agency (EMA) revived agreement talks concerning the cGMP provisions. Starting in 2012 with the passage[…]